SIMULTANEOUS DETERMINATION OF PRAMOCAINE HCL AND HYDROCORTISONE ACETATE IN PHARMACEUTICAL DOSAGE FORM

Abstract

Two sensitive and selective methods were developed and validated for simultaneous determination of pramocaine HCl and hydrocortisone acetate in pharmaceutical dosage form. The first method is a spectrodensitometric method where pramocaine HCl and hydrocortisone acetate were separated using toluene:methanol:chloroform: 10% NH₃ [(5:3:6:0.1, by volume) as the developing system followed by densitometric measurement at 290 nm] and 250 nm for pramocaine HCl and Hydrocortisone acetate, respectively. The second method is a high performance liquid chromatographic method for separation and determination of both drugs using reversed phase C₁₈ column and mobile phase consisting of distilled water:acetonitrile:triethylamine (530:470:0.1, by volume); pH was adjusted to 3 by o-phosphoric acid. The proposed methods were successfully applied for the analysis of pramocaine HCl and hydrocortisone acetate in laboratory prepared mixtures and in pharmaceutical dosage form and the results obtained were assessed by applying the standard addition technique. Statistical comparison between the results obtained by applying the proposed methods and official method for the cited drugs was done and no significant difference was found at p = 0.05.

Keywords:

• hydrocortisone acetate
• pramocaine HCL
• pramoxine HCL
• reversed phase high performance liquid chromatography
• spectrodensitometry

Notes

^a Intra-day precision n = 3 × 3.

^b Interday precision n = 3 × 3.

^c Triplicate HPLC determination of 20, 40, and 80 µg/mL for PR and 50, 150, and 250 µg/mL for HCA, triplicate densitometric determination of 4, 16, and 28 µg/spot for PR and 20, 40, and 80 µg/spot for HCA.

^d Variation of mobile phase or developing solvent composition ± 2%.

^e Variation in pH ± 0.2.

*Batch No. 92308.

*The values between parenthesis are the theoretical values of t and F at (p = 0.05).